Treatment of Primary Membranous Nephropathy with a New Monoclonal Antibody

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase I clinical study evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of a recombinant humanized anti-CD20 monoclonal antibody administered via subcutaneous injection for patients with primary membranous nephropathy. The study aims to determine preliminary efficacy and gather data on how the drug behaves in the body. Participants will be closely monitored to assess their response to the treatment and any potential side effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subjects who have fully understood this study and voluntarily signed the informed consent form;
2. Male or female subjects, aged between 18 and 75 years;
3. Subjects with primary membranous nephropathy pathologically confirmed by renal biopsy;
4. Subjects with systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90 mmHg at screening;
5. If taking ACEI(Angiotensin converting enzyme inhibitors), ARB(Angiotensin receptor blocker), a stable dose within 4 weeks before screening is required;
6. Subjects who are able to follow the study protocol as judged by the investigator.

Exclusion Criteria:

1. Subjects with secondary membranous nephropathy;
2. Subjects with uncontrolled blood pressure as judged by the investigator within 3 months before screening;
3. Subjects with decreases in urine protein ≥ 50% within 6 months before screening;
4. Subjects who have received or are receiving renal replacement therapy;
5. Subjects with type 1 diabetes mellitus, or those with type 2 diabetes mellitus who are diagnosed as diabetic nephropathy by percutaneous renal biopsy;
6. Subjects who have a clear history of tuberculosis or have received anti-tuberculosis treatment;
7. Subjects with active bacterial, viral, fungal, mycobacterial, parasitic or other infections requiring systemic antibiotics or antiviral therapy;
8. Subjects with known history of severe allergic reactions to humanized monoclonal antibodies；
9. Subjects who received live vaccination, major surgery, or participated in other clinical trials within 28 days before receiving the study drug;
10. Pregnant or lactating women; women of childbearing potential who have not been sterilized do not agree to use appropriate contraceptive measures during treatment and for at least 12 months after the last dose of the study drug;
11. Subjects with serious, progressive, or uncontrolled disease that may increase risks during the participation in the study as assessed by the investigator;
12. Subjects with a history of alcoholism or drug abuse within 12 months;
13. Subjects with positive hepatitis B surface antigen; those with positive hepatitis C virus antibody; those with a history of immunodeficiency;
14. Subjects with CD4+ T lymphocyte count \< 300 cells/μL;
15. Other conditions unsuitable for participation in this study determined by the Investigator.

Where it's running

• The First Affiliated Hospital of Zhengzhou University
  Zhengzhou, He'nan, China Recruiting
• Hebei General Hospital
  Shijiazhuang, Hebei, China Recruiting
• The First Affiliated Hospital,College of Medicine,Zhejiang University
  Hangzhou, Zhejiang, China Recruiting
• Peking university first hospital
  Beijing, China Recruiting
• Longhua Hospital Shanghai University of Traditional Chinese Medicine
  Shanghai, China Recruiting
• Longhua Hospital Shanghai University of Traditional Chinese Medicine
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Minghui Zhao
• Email: mhzhao@bjmu.edu.cn
• Phone: 0086-13501243815

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Surovatamig for adults with anti‑PLA2R primary membranous nephropathy

  This study will test whether subcutaneous surovatamig is safe and can reduce heavy proteinuria in adults with anti‑PLA2R–positive primary membranous nephropathy.

  Recruiting Phase 2 AstraZeneca · Los Angeles, California and 26 other locations · NCT07571746

• SHR-2173 injections for adults with primary membranous nephropathy

  This Phase II test will try SHR-2173 injections in adults (18–75) with biopsy-proven primary membranous nephropathy to see if they are safe, reduce disease activity, and to measure how the drug acts in the body.

  Recruiting Phase 2 Guangdong Hengrui Pharmaceutical Co., Ltd · Nanjing, Jiangsu · NCT07289763

• Povetacicept for people with primary membranous nephropathy

  This trial tests whether povetacicept is safe and helps people with primary membranous nephropathy, with tacrolimus listed as an intervention in the protocol.

  Recruiting at 116 sites Phase 2/3 Vertex Pharmaceuticals Incorporated · Montgomery, Alabama and 116 other locations · NCT07204275

• ALXN1920 for adults with primary membranous nephropathy

  This trial will test whether ALXN1920 reduces urine protein in adults with primary membranous nephropathy who are at high risk of progression compared with placebo.

  Recruiting at 35 sites Phase 2 Alexion Pharmaceuticals, Inc. · Loma Linda, California and 39 other locations · NCT07157787

• Budoprutug for primary membranous nephropathy (Phase 2)

  This trial will test whether budoprutug, an anti-CD19 antibody given by IV, is safe and tolerated and may reduce proteinuria in adults with PLA2R-positive primary membranous nephropathy who still have high protein in their urine despite RAAS blockers.

  Recruiting at 35 sites Phase 2 Climb Bio, Inc. · Denver, Colorado and 37 other locations · NCT07096843

• Evaluating YK012 for treating primary membranous nephropathy

  This study is testing a new treatment called YK012 to see if it can help people with primary membranous nephropathy feel better and how safe it is to use.

  Recruiting Phase 1 Excyte Biopharma Ltd · Beijing, Beijing Municipality · NCT06982729

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.